REACH24H Consulting Group

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ECHA to Review Completeness of over 800 Registrations

According to the news released on April 8, 2016 by ECHA, over 8000 REACH registration dossiers in total will be reopened for completeness checks to uphold the “one substance, one registration” principle. The first set will be the 118 charcoal dossiers, following the decision of last month’s Board of Appeal ruling. ECHA will also recheck all dossiers which may be in breach of the joint registration principle of REACH. This means that approximately 700 individual registrations submitted under the REACH Regulation will be reopened, representing 1.5% of all registrations. At the same time, ECHA will recheck the completeness of the dossiers in its database with regard to the information requirements to verify that the information provided is meaningful. It is highly suggested that companies registered individually keep close contact with their OR.

ECHA suggests that companies check the relevance of the information that they have submitted and make sure that the ‘one substance, one registration' principle is followed. They are encouraged to proactively update their registrations as soon as possible if needed. If a dossier is found to be incomplete after the retroactive completeness check, the registrant will be given a reasonable amount of time to update their dossier with the missing information. If they provide the information within the deadline and fulfil the joint submission obligation, they can remain on the market without interruption. Otherwise, the registration will lose its validity and the company will lose market access.

Also, an enhanced automated completeness check will be available later this year with the launch of the new version of REACH-IT. But a manual verification of certain data elements that cannot be checked automatically is still needed, which will prevent registrants from misusing the system by adding irrelevant information to bypass an information requirement, for new submissions and for updates of an existing registration.

The news also mentions that ECHA's Helpdesk will assist companies intending to join the joint submission or share data. If the negotiations for sharing data and joining a joint submission fail after every effort to reach an agreement has been made, registrants can file a data-sharing dispute to ECHA free-of-charge.

The upcoming move of completeness checks to be taken by ECHA is in line with the new implementing regulation to clarify the “fair, transparent and non-discriminatory” principles for data sharing under EU REACH, which came into force on 26 January, 2016, which gives ECHA the mandate to champion the “one substance, one registration” principle in the REACH regulation. Meanwhile, ECHA took into consideration various uncertainties and provided registrants with a means to solve disputes.

To properly deal with the upcoming checks, REACH24H suggests that:

1. For substances with available joint registration, REACH24H suggest potential registrants to get a clear understanding of cost sharing for the required data and communicate actively with the Lead Registrant( LR). For unreasonable cost sharing practices, potential registrants could appeal to ECHA.

2. For substances without joint submission dossiers, REACH24H suggest potential registrants to play the role of LR and take the initiative to set rules for cost sharing.

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ECHA to review completeness of registrations

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